At ASH 2017, Dr. Jennifer Brown, the Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute and an Associate Professor of Medicine at Harvard Medical School in Boston, Massachusetts, looked back at and combined the data from several trials to assess the risk of bleeding in CLL patients on ibrutinib compared to those taking other treatments.

Major hemorrhage in chronic lymphocytic leukemia patients taking ibrutinib has been a worry since the very early trials. The results of Dr. Brown’s research were mostly reassuring.

Take Away Points:

The rate of major hemorrhage was 3% in patients being treated with ibrutinib.

There was little difference in the bleeding risk between all the CLL patients taking ibrutinib and those on the other comparator therapies.

This was also true for those patients taking anti-platelet or anti-coagulant medications where the risks are slightly higher for both groups.

The exception was brain and fatal hemorrhage that occurred exclusively in patients being treated with ibrutinib, however there were fewer than 10 such bleeds in the 750 patients studied.

The number was too small to see any pattern, but the risk may be increased with those with a prior history of bleeding and those on other medications that increase bleeding risk, especially warfarin. The newer oral anti-coagulants are probably safer. Aspirin, used for its anti-platelet activity is also probably safe to use with ibrutinib.

Major hemorrhage led to discontinuation of ibrutinib in only 1% of patients.

Conclusions:

Ibrutinib can be used, with appropriate precautions, in many patients that require anti-coagulant or anti-platelet therapy. Warfarin (Coumadin) is probably best avoided.